Child depression is among the most prevalent and impairing pediatric conditions and constitutes a major public health concern. Unfortunately, treatment benefits are relatively modest and short-lived with sizeable percentages of children who maintain depressive symptoms following treatment. This problem may be addressed in part by personalizing treatment, including determining which children will benefit from caregiver involvement in treatment. The goal of the current proposal is to pilot test an innovative experimental design called Sequential, Multiple Assignment, Randomized Trial (SMART), which is used for development of personalized treatments, and assess the acceptability and feasibility of using this design, in preparation for a full-scale SMART in a larger clinical trial and for the development of personalized treatment.

Semi-structured diagnostic interview with children and caregivers assessing present episode and lifetime history of psychiatric illness. All modules will be administered at pre-treatment to establish depression as a primary disorder. In later assessment points, only depression module will be administered.

Children will first be randomized into one of two initial treatments: individual Cognitive Behavioral Treatment (CBT) or Caregiver-Child Treatment. The individual CBT arm will be conducted once per week for six weeks. After the initial treatment, child's response to treatment will be evaluated. Responders will be re-randomized into no treatment or individual CBT (these sessions will focus on mastering the skills and enhancing fluency in use of the skills). Non-responders will be re-randomized into one of two treatments: individual CBT or Caregiver-Child Treatment. Sessions will be conducted once per week.

Children will first be randomized into one of two initial treatments: individual Cognitive Behavioral Treatment (CBT) or Caregiver-Child Treatment. The caregiver-child treatment arm will be conducted once per week for six weeks. After the initial treatment, child's response to treatment will be evaluated. Responders will be re-randomized into no treatment or Caregiver-Child Treatment (these sessions will focus on mastering the skills and enhancing fluency in use of the skills). Non-responders will be re-randomized into one of two treatments: Caregiver-Child Treatment or individual CBT. Sessions will be conducted once per week.

Childhood depression constitutes a major public health concern, requiring effective interventions. The effects of treatments for childhood depression are relatively modest and short-lived, with sizeable percentages of children who maintain depressive symptoms following treatment. A potential barrier to treatment success is the single uniform format of treatment protocols, addressing all depressed children similarly, regardless of clinical presentation. One strategy for addressing this barrier is to personalize treatment, fitting intervention to the specific needs of the children being targeted. This approach is consistent with the strategic plan of the National Institute of Mental Health (NIMH) to emphasize the development of personalized interventions.

Studies have documented the importance of family context in the development and maintenance of childhood depression; however, the limited number of clinical trials that involved caregivers provided mixed results, with only some youths benefiting from caregiver involvement in treatment. A logical first step in personalizing treatment is to develop decision rules about which children are likely to benefit from caregiver involvement in treatment, and at what point in treatment caregiver involvement should occur. The proposed study will take the first step toward addressing these key personalizing questions, using the Sequential, Multiple Assignment, Randomized Trial (SMART) design, an experimental method that is well-suited to the development of personalized treatments.

The proposed project will focus on the first step in the development of personalized treatment for depressed children, piloting use of the SMART design. The study has two aims. Aim 1 includes the refinement of the individual CBT and caregiver-child treatment manuals for use in the SMART trial. Aim 2 includes a pilot study of the SMART experimental design, with 48, 7-14 year-old children who meet criteria for Major Depressive Disorder and/or Dysthymic Disorder. The pilot study will provide information about the acceptability of the treatment manuals, assessments, and study procedures and about the feasibility of the two-step randomization used in the SMART design. The resulting information will inform the development of a full-scale properly-powered SMART trial (for a later study). The long-term objective is to use the SMART trial methods to guide development of personalized treatment for child depression.

If receiving psychiatric medication, dose should be stable for at least three months at enrollment.

Exclusion Criteria:

A disorder other than depression as primary diagnosis.

Autism Spectrum Disorders.

Psychotic Disorders.

Suicidal behavior.

Participation in additional psychotherapy.

Caregiver and/or children do not speak English.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01880814